Portable manual ventilation device

ABSTRACT

A portable, compact closed circuit ventilation device for manual ventilation of a patient undergoing a surgical or medical procedure that requires sedation as well as emergency management of respiratory failure. One example embodiment includes a closed breathing circuit having a manually squeezable bag, a carbon dioxide absorption canister, a plurality of valves, a gas port and a plurality of sensors for measuring Tidal Volume (TV), Peak Airway Pressure (PAP) and End Tidal CO2 (ETCO2). Another example embodiment includes an open breathing circuit having a bag, valves and sensors. A monitor displays the sensor measurements during the respiratory phases. In a spontaneously breathing patient the device may be used to assess the adequacy of patient&#39;s respiratory efforts. During manual or assisted ventilation, the monitor assures safe and efficacious ventilation by the closed breathing circuit.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a division of the nonprovisional patent application,Ser. No. 14/151,486, filed in the U. S. Pat. Office on Jan. 9, 2014 andclaims the priority thereof and is expressly incorporated herein byreference in its entirety.

TECHNICAL FIELD

The present disclosure relates generally to a medical ventilationdevice. More particularly, the present disclosure relates to a portablemanual circuit ventilation device and system for use during medicalprocedures requiring anesthesia, as well as emergency management ofrespiratory failure.

BACKGROUND

The development of modern surgery began when doctors startedadministering anesthesia to the patients before and during surgicalprocedures. Anesthesia blocks or removes sensation particularly thefeeling of pain, allowing the surgeon to perform surgery withoutpatients experiencing extreme distress and pain they would otherwiseundergo. Anesthesia produces a medically induced coma and a loss ofprotective reflexes from one or more medications resulting in amnesia,analgesia, muscle relaxation and sleep.

In standard operating rooms, an anesthesiologist administers generalanesthesia through large machines that are connected to the patient'srespiratory system. Drugs used to induce general anesthesia areadministered through inhalation and/or injection. Most commonly,anesthesia is induced by injection and maintained through inhalation.

During general anesthesia, the patient is not breathing on his own, butthrough a closed system of the anesthesia machine. The most common typeanesthesia machine is a continuous flow, which is designed to supplyoxygen, anesthetic drug as a gas and ambient air to the patient. As aclosed system, respiratory parameters are easily monitored. Not only isthe amount of anesthetic drug accurately monitored, but also manyparameters such as oxygen saturation, as well as inspired and expiredgases. The anesthesia machine, because of its complexity, size andinfrastructure requirements, is typically rooted to the traditionaloperating room.

Now many medical procedures, both surgical and non-surgical, areperformed outside the operating room in various hospital suites,ambulatory surgical suites and doctors' offices. Most proceduresperformed outside of a traditional operating room require ananesthesiologist to administer sedation, not general anesthesia.Generally, the sedating drugs are administered by injection and not byinhalation. Because no drugs are administered by inhalation, theanesthesia machine is not required and remains a fixture only in thetraditional hospital operating room. The patient breathes on his ownduring the procedure.

Often the patient stops breathing and needs to be resuscitated with abag-valve-mask, such as an AMBU® bag, (AMBU® is the registered trademarkof AMBU NS, Ballerup, Denmark) to start breathing again. The patient hasbeen breathing on his own up to this point and the respiratory system isnot coupled to any mechanical ventilation device.

The bag-valve-mask is the only tool available in most surgical suitesand offices and it is very limited in function. The bag-valve-mask andvalve is coupled to either a face mask secured to the patient's face orthrough an endotracheal tube. Ambient air is pushed into the lungsthrough a one-way valve when the bag is compressed by anesthesiologistor assistant. Once the bag has emptied into the lungs and released, itinflates from the other end and the air in the lungs is automaticallyexpelled into ambient air, the bag-valve-mask constituting an opencircuit system. The bag is compressed again for the next breath.

The amount and pressure of air entering the lungs is determined by theperson compressing the bag. Generally bag-valve-masks are without anygauges, so only the experience and skill of the person compressing thebag protects the patient's lungs from over-inflating orover-pressurization. The person compressing the bag can only tell byexternal signs that the lungs are inflating properly, that air is notleaking from the mask or tracheal tube and the patient is properly beingresuscitated.

The bag-valve-mask is further limited in mask ventilation situationswhen the patient has anatomic airway anomalies or is obese so that themask does not fit tightly and seal around the nose and mouth. Withoutany gauges, the bag -valve-mask does not provide any objective method toassess adequacy of ventilation. In this situation, inadequateventilation can lead to hypoxia and brain death.

While these units may be suitable for the particular purpose employed,or for general use, they would not be as suitable for the purposes ofthe present disclosure as disclosed hereafter.

In the present disclosure, where a document, act or item of knowledge isreferred to or discussed, this reference or discussion is not anadmission that the document, act or item of knowledge or any combinationthereof was at the priority date, publicly available, known to thepublic, part of common general knowledge or otherwise constitutes priorart under the applicable statutory provisions; or is known to berelevant to an attempt to solve any problem with which the presentdisclosure is concerned.

While certain aspects of conventional technologies have been discussedto facilitate the present disclosure, no technical aspects aredisclaimed and it is contemplated that the claims may encompass one ormore of the conventional technical aspects discussed herein.

BRIEF SUMMARY

An aspect of an example embodiment in the present disclosure is tomaximize patient safety during a surgical or medical procedure thatrequires sedation, but not general anesthesia. Accordingly, the presentdisclosure provides a portable, compact ventilation device for manualresuscitation that mounts on a wheeled stand for use in clinicalapplications where space is limited and only manual ventilation isavailable.

Another aspect of an example embodiment in the present disclosure is toprovide superior sedation during a surgical or medical procedure thatrequires sedation, but not general anesthesia. According the presentdisclosure provides monitoring of ventilation quality so that optimallevels of sedation that do not endanger the patient but alleviate painand maintain unconsciousness can be administered, producing superiorsedation.

A further aspect of an example embodiment in the present disclosure isto provide a system where measurements of ventilation quality can bemonitored during resuscitation. Accordingly, the present disclosureprovides a breathing circuit, so that measurements of tidal volume, endtidal carbon dioxide concentration and peak airway pressure indicativeof ventilation quality can be measured.

Accordingly, the present disclosure describes a portable, compactcircuit ventilation device for manually ventilating a patient undergoinga surgical or medical procedure that requires sedation, but not generalanesthesia, as well as emergency management of respiratory failure, inwhich only manual ventilation is available. The device includes abreathing circuit having a manually squeezable bag, a carbon dioxideabsorption canister, a plurality of valves, a gas port, and a pluralityof sensors for measuring TV (tidal volume), PAP (peak airway pressure)and ETCO2 (end tidal carbon dioxide). In one example embodiment, thedevice is a closed circuit having a carbon dioxide absorption canister.In one example embodiment, the device includes a monitor operative fordisplaying the measurement for each sensor as the squeezable bag iscompressed, manually ventilating a patient, the monitor assuring safeand efficacious manual ventilation by the closed breathing circuit.

The present disclosure addresses at least one of the foregoingdisadvantages. However, it is contemplated that the present disclosuremay prove useful in addressing other problems and deficiencies in anumber of technical areas. Therefore, the claims should not necessarilybe construed as limited to addressing any of the particular problems ordeficiencies discussed hereinabove. To the accomplishment of the above,this disclosure may be embodied in the form illustrated in theaccompanying drawings. Attention is called to the fact, however, thatthe drawings are illustrative only. Variations are contemplated as beingpart of the disclosure.

BRIEF DESCRIPTION OF THE DRAWINGS

In the drawings, like elements are depicted by like reference numerals.The drawings are briefly described as follows.

FIG. 1 is a perspective view of an example embodiment of a closedbreathing circuit of a portable closed circuit ventilation device.

FIG. 2 is a perspective view of the portable closed circuit ventilationsystem.

FIG. 3 is a perspective view of a further example embodiment of an openbreathing circuit showing a valve in cross-section.

FIG. 4 is a perspective view of another example embodiment of a portableopen breathing circuit ventilation device.

The present disclosure now will be described more fully hereinafter withreference to the accompanying drawings, which show various exampleembodiments. However, the present disclosure may be embodied in manydifferent forms and should not be construed as limited to the exampleembodiments set forth herein. Rather, these example embodiments areprovided so that the present disclosure is thorough, complete and fullyconveys the scope of the present disclosure to those skilled in the art.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

FIG. 1 illustrates a closed breathing circuit 10 of a portable closedcircuit ventilation device for manually ventilating a patient. Theportable closed circuit ventilation device is useful for clinicalapplications for patients who are undergoing surgical and medicalprocedures that require sedation, but not general anesthesia, as well asemergency management of respiratory failure throughout the hospital. Theuniqueness of the described closed circuit device is in the small size,portability and is discrete and independent from other equipment.Structurally it is simpler and very different from the traditionalanesthesia machine, allowing it to be used for very differentapplications and functions.

By clinical applications, reference is made to, but not limited to, sameday surgical suites, either within a hospital campus or at anindependent location, outpatient clinics and physicians' offices wherepatients undergo sedation. These procedures in clinical applicationsencompass surgery of many types, endoscopy, pain management, colonoscopyand other diagnostic procedures, as non-limiting examples. Additionally,the closed circuit ventilation device is useful for manually assistingventilation by face mask before an endotracheal tube is inserted intothe patient and secured.

In these clinical applications, traditional anesthesia machines are notpractical nor cost effective for several reasons. These machines aredesigned for use in a traditional hospital operating room for drugdelivery by inhalation. In order to regulate the dosage and rate of drugdelivery, the patient's breathing is commonly machine-regulated andnon-spontaneous, the machine continuously controlling the patient'sbreathing. The machines require highly trained specialists, areexpensive to operate and require a large amount of space.

In clinical applications, medical personal depend on a bag-valve-mask inan open breathing circuit if resuscitation of the patient is required.In a standard open breathing circuit, the ability to measure a pluralityof parameters such as, for example, not limited to, peak airway pressure(PAP), tidal volume (TV), and end tidal carbon dioxide concentration(ETCO2) is lacking. The standard open circuit that has thebag-valve-mask is not designed to measure these parameters.

FIG. 1 shows a closed breathing circuit of the device having a manuallysqueezable bag 20, a carbon dioxide absorption canister 30, a pluralityof valves, namely an inspiratory valve 14, an expiratory valve 16, avalve 18 and a gas port 12 operative for allowing gases such as air andoxygen to be added to the circuit as necessary. The bag 20, canister 30,the inspiratory valve 14, the expiratory valve 16, the valve 18 and port12 are coupled by a tubing 36 and are in fluid communication within thecircuit 10. The circuit has an expiratory intersection 10E andinspiratory intersection 10N for connecting to a face mask on a patient,which is not shown. In another example embodiment, the expiratoryintersection 10E and inspiratory intersection 10N are operative forconnecting the circuit, which in turn is operative for connecting via aface mask or artificial airway to the patient. Face masks and artificialairways are well-known to those of ordinary skill and further detailsare beyond the scope of the present disclosure.

The carbon dioxide absorption canister 20 is part of the closed circuitoperative for preventing a buildup of excess carbon dioxide produced bythe patient in the closed circuit to prevent hypercapnia. The canistercontains a solid chemical compound with a high affinity for carbondioxide, such as, as a non-limiting example, soda lime.

The bag 20 is for manual resuscitation when the device is in use.Ventilation is only in a manual mode. Respiration by a patient is eitherspontaneous and unassisted, or manual when spontaneous breathing isinadequate or ceases. The squeezable bag is manually pumped by themedical personal to resuscitate the patient, such that the gases in thesystem move only when the patient breathes or when the bag is squeezed.The squeezable bag can be, for example, a bag-valve-mask, aself-inflating bag, a soft non-self inflating bag or other types ofresuscitation bags and the type of squeezable bag is not a limitation inthe present disclosure.

In the example embodiment in FIG. 1, the closed circuit has a set ofone-way valves, the expiratory valve 16, in proximity to the expiratoryintersection 10 E and the inspiratory valve 14, in proximity to theinspiratory intersection 10N that permit the flow of gases only in onedirection. The circuit 10 also has an adjustable pressure relief valveoperative for maintaining pressure in the system operative to preventover-inflating the patient's lungs causing volutrauma, by overstretching the lungs, barotrauma, by over pressuring the lungs andgastric insufflation.

The tubing 36 has an interior and in the interior is a plurality ofsensors, namely a peak airway pressure sensor 22 inside port 22P and aflow tidal volume (TV) sensor inside port 24P, the sensors operative formeasuring a plurality of parameters within the closed breathing circuit.A sensor is a device that measures a parameter and converts it into asignal, which can be read by the monitor. It is understood by those ofordinary skill that the sensors can be electrical, electronic,mechanical or biomechanical and that the type of sensor used is not alimitation of example embodiments presented herein. The sensors producea measurement for the parameters associated with effective ventilationand resuscitation.

In the present example embodiment, the flow tidal volume (TV) sensor 24is in proximity to the expiratory valve 16 and the expiratory interface10E, operative for measuring return tidal volume of expired gas from thepatient, indicative of the effectiveness of the respiration. Inproximity to the inspiratory valve 14 and the inspiratory interface 10N,is the peak airway pressure sensor 22, indicating the peak airwaypressure (PAP) operative for monitoring to prevent barotrauma,volutrauma and gastric insufflation. An additional sensor operative formeasuring end tidal carbon dioxide concentration (ETCO2), operative forpreventing hypercapnia is discussed hereinbelow.

In one example embodiment, the sensors are connected to wire leads to apower source and communicate measurements to a monitor describedhereinbelow. In another example embodiment, the sensors are batterypowered and communicate wirelessly to the monitor.

In one example embodiment, the closed breathing circuit 10 includesdisposable, single use valves, ports, tubing, bag and canister operativefor interfacing with the monitor described herein below.

FIG. 4 illustrates a monitor 50coupled to an open breathing circuit 10.The monitor has a display screen 54 for displaying the parametersmeasured by the sensors. The monitor is coupled to the sensors. In thisexample embodiment, each said sensor has a lead 44 connecting to themonitor 50. In another example embodiment, tubing operative forconducting air to the monitor connects to the monitor. It is understoodby those of ordinary skill that the lead can be tubing, electricalwiring or other means of connecting the sensors to the monitor. Themonitor displays on the display screen 54 the measurements for eachparameter as the squeezable bag 20 is compressed, manually ventilating apatient. The monitor has internal electronic circuitry and softwareoperative for displaying the measurements in a variety of formatsincluding graphical displays such as curves. The monitor has an internalalarm system operative for sounding an audio alert when a measuredparameter measures outside a pre-set range. The monitor has a set ofcontrols 52, shown here as analog dials, as a non-limiting illustrationoperative for setting said pre-set range and an alert level. In otherexample embodiments, the controls are digital. Monitors are well knownto those of ordinary skill and discussion of further details of themonitor is outside the scope of this disclosure.

The monitor 50 can be mounted on a stand 56 as shown, a wall or can beused independently. The stand 56 is selectively adjustable in height.The monitor can be powered by AC or DC current, the DC current poweredby a battery, preferably rechargeable.

In the configuration of the manual open circuit ventilation device 8 inFIG. 4, the gas port is opposite a single-shutter valve 28, allowingconnecting tubing 32 for the gas inflow to attach directly to the bag20. The patient outflow comes through a port 34, the port coupling theclosed circuit to the patient, either by coupling to a face mask orartificial airway. In this example embodiment, the single shutter valvereplaces the pair of valves, the inspiratory valve and expiratory valve,the single-shutter valve functioning as both. In FIG. 4, the valve isopen to the expiratory side, the expired gases from the patient passingover the ETCO2 sensor 26 for measurement. Downstream is the TV sensor24, the three sensors connecting to the monitor by leads 44, the gasesflowing to the expiratory side intersection. When the inspiratory gaspasses over sensor 22, PAP is measured.

In FIG. 3, in a further example embodiment, the configuration of theopen breathing circuit has the connecting tube 32 for the gas inflowcoupled to the squeezable bag through a valve 60. The single-shuttervalve 28 is open to the inspiratory side. The single-shutter valve 28has a shutter 38 that opens the path to the patient via the inspiratoryside intersection with positive air pressure provided by squeezing thebag 20. PAP is measured during the inspiratory phase via the PAP sensor22 and ETCO2 and TV are measured during the expiratory phase via theETCO2 sensor 26 and the TV sensor 24.

FIG. 2 shows portable ventilation system 40 for manually ventilating thepatient in clinical applications. The system has the manual closedcircuit ventilation device, having the monitor 50 and the closedbreathing circuit. The system has a housing 62 having a plurality ofopenings 64 operative for coupling tubing to the closed breathingcircuit. A portion of the closed breathing circuit as described invarious example embodiments hereinabove, namely, the valves, tubing, thecarbon dioxide absorption canister and sensors, said portion is enclosedin the housing. The squeezable bag 20 of the circuit is external to thehousing and is coupled to the circuit by a pivoting joint 66. Theexpiratory side intersection 10E and the inspiratory side intersection10N extend through the openings 64 operative for coupling to aventilation interface such as a mask or an artificial airway. Theconnecting tubing 32 for the gas inflow extends through another opening.

The system has a portable stand 56, having a top 56T and a bottom 56B,the bottom having wheels 68, the top 56T coupled to the monitor, themonitor on top of the stand external to the housing 62. The housing hasthe closed breathing circuit coupled to the stand 56 between the top 56Tand the bottom 56B. The stand 56 can portably wheel to a patientrequiring ventilation. The monitor 50 on the stand displays on thedisplay screen 54, the measurement for each parameter measured by thesensors as the squeezable bag 20 is compressed, manually ventilating thepatient, the monitor assuring safe and efficacious manual ventilation bythe closed breathing circuit. Further, TV and ETCO2 are measurable whilethe patient is breathing spontaneous as well.

In one example embodiment, the sensors have leads to the monitor, theleads enclosed by the housing and stand. In a further exampleembodiment, the sensors are in communication with the monitor throughtubing. In other example embodiments, the sensors communicate wirelesslyto the monitor.

Referring to FIG. 2, the patient has been sedated undergoing a clinicalprocedure or surgery. No gaseous anesthesia is administered. The patientis breathing on his own without a traditional anesthesia machine. Thepatient stops breathing and requires resuscitation. Medical personnelwheel the portable ventilation system to the patient. The closedbreathing circuit 10 within the housing is connected via tubing 32 to asource of gas, such as oxygen, and the monitor 50 is turned on. Aventilation mask is placed over the patient's face. The medicalpersonnel squeeze the bag 20, resuscitating the patient while watchingthe screen 54 where the measurements of TV, PAP and ETCO2 are displayed,adjusting the squeezing of the bag 20 to produce effective ventilation.

The manual closed circuit ventilation device as illustrated in FIG. 1 ismade by connecting the manually squeezable bag 20, the carbon dioxideabsorption canister 30, the valves, namely the inspiratory valvel4, theexpiratory valve 16, and valve 18 and the gas port 12, all in fluidcommunication via tubing 36. The tubing has the expiratory intersection10E and the inspiratory intersection 10N for further coupling with amask or artificial airway. The sensors 22, 24, and the ETCO2 sensor,which is not shown in this illustration, are coupled to the interior ofthe tubing. The sensors are coupled to and in communication with amonitor.

It is understood that when an element is referred hereinabove as being“on” another element, it can be directly on the other element orintervening elements may be present therebetween. In contrast, when anelement is referred to as being “directly on” another element, there areno intervening elements present.

Moreover, any components or materials can be formed from a same,structurally continuous piece or separately fabricated and connected.

It is further understood that, although ordinal terms, such as, “first,”“second,” “third,” are used herein to describe various elements,components, regions, layers and/or sections, these elements, components,regions, layers and/or sections should not be limited by these terms.These terms are only used to distinguish one element, component, region,layer or section from another element, component, region, layer orsection. Thus, “a first element,” “component,” “region,” “layer” or“section” discussed below could be termed a second element, component,region, layer or section without departing from the teachings herein.

Spatially relative terms, such as “beneath,” “below,” “lower,” “above,”“upper” and the like, are used herein for ease of description todescribe one element or feature's relationship to another element(s) orfeature(s) as illustrated in the figures. It is understood that thespatially relative terms are intended to encompass differentorientations of the device in use or operation in addition to theorientation depicted in the figures. For example, if the device in thefigures is turned over, elements described as “below” or “beneath” otherelements or features would then be oriented “above” the other elementsor features. Thus, the example term “below” can encompass both anorientation of above and below. The device can be otherwise oriented(rotated 90 degrees or at other orientations) and the spatially relativedescriptors used herein interpreted accordingly.

Example embodiments are described herein with reference to cross sectionillustrations that are schematic illustrations of idealized embodiments.As such, variations from the shapes of the illustrations as a result,for example, of manufacturing techniques and/or tolerances, are to beexpected. Thus, example embodiments described herein should not beconstrued as limited to the particular shapes of regions as illustratedherein, but are to include deviations in shapes that result, forexample, from manufacturing. For example, a region illustrated ordescribed as flat may, typically, have rough and/or nonlinear features.Moreover, sharp angles that are illustrated may be rounded. Thus, theregions illustrated in the figures are schematic in nature and theirshapes are not intended to illustrate the precise shape of a region andare not intended to limit the scope of the present claims.

In conclusion, herein is presented a portable manual ventilation device.The disclosure is illustrated by example in the drawing figures, andthroughout the written description. It should be understood thatnumerous variations are possible, while adhering to the inventiveconcept. Such variations are contemplated as being a part of the presentdisclosure.

What is claimed is:
 1. A portable open circuit ventilation device formanually ventilating a patient in clinical applications, comprising: anopen breathing circuit having a manually squeezable bag, said bag havingan inflow port, a single-shutter valve, an outflow port operative forcoupling to a ventilation mask, tubing having an interior, saidsqueezable bag, said valve, said port, said mask intersection coupled bysaid tubing and in fluid communication in the open breathing circuit; aplurality of sensors, said sensors operative for measuring a pluralityof parameters within the open breathing circuit, said sensors producinga measurement for a parameter, said sensor coupled to said tubinginterior; and a monitor, said monitor having a display screen, saidmonitor coupled to said sensors, said monitor displaying on said displayscreen said measurement for the measured parameter as said squeezablebag is compressed, manually ventilating a patient, the monitor assuringsafe and efficacious manual ventilation by the open breathing circuit.2. The device as described in claim 1, wherein the parameters measuredby said sensors in the open breathing circuit comprise tidal air volume,peak airway pressure and end tidal carbon dioxide concentration, saidend tidal carbon dioxide within said tubing within the same circuit assaid tidal air volume sensor and said peak airway pressure sensor. 3.The device as described in claim 2, wherein said monitor has an alarmsystem, said system operative for sounding an audio alert when ameasured parameter measures outside a pre-set range.
 4. The device asdescribed in claim 3, wherein ventilation is only in a manual mode.